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Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined using a Shimadzu SALD -3000J (SALD 200-WJA1: V1.21) laser diffraction particle size analyser, with water as a disperging material. Scanning electrion microscopy images of the 1-5 µm sample were included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
D50
Mean:
3.211 µm
Remarks on result:
other: Average 3.168 µm standard deviation 0.146
Percentile:
other: D25
Mean:
2.672 µm
Remarks on result:
other: 25% of the particles were distributed at 2.672 µm
Percentile:
D50
Mean:
3.211 µm
Remarks on result:
other: 50% of the particles were distributed at 3.211µm
Percentile:
other: D75
Mean:
3.845 µm
Remarks on result:
other: 75% of the particles were distributed at 3.845 µm.
Conclusions:
The median diameter of the particles was reported to be 3.211 µm.
Executive summary:

The median diameter of the particles was reported to be 3.211 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined using a Shimadzu SALD -3000J laser diffraction particle size analyser. Scanning electrion microscopy images of the 5 µm sample were included.
GLP compliance:
no
Type of distribution:
volumetric distribution
Percentile:
D99
Mean:
8 µm
Remarks on result:
other: 99.987 % of the particles were distributed below 8 µm, 99.9760 % were 5.500 µm and less
Percentile:
other: D70
Mean:
3.5 µm
Remarks on result:
other: 70.918 % were 3.5 µm or below
Percentile:
other: D45
Mean:
3 µm
Remarks on result:
other: 43.897 % of particles were 3 µm or less
Conclusions:
The majority of the distribution was found between 3 and 3.5 µm.
Executive summary:

The majority of the particles were found to fall between 3 and 3.5 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D 90
Mean:
5 - 11 µm
Remarks on result:
other: 92.13 % were found to be between 5 and 11 µm.
Conclusions:
The majority of particles were found to be between 5 and 11 µm.
Executive summary:

5 -11 µm accounted for the majority of the distribution of the particles.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D 90
Mean:
5 - 11 µm
Remarks on result:
other: 88.50 % were found to be between 5 and 11 µm.
Conclusions:
The majority of particles were found to be between 5 and 11 µm.
Executive summary:

5 -11 µm accounted for the majority of the distribution of the particles.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D75
Mean:
5 - 11 µm
Remarks on result:
other: 75.34 % were found to be between 5 and 11 µm.
Conclusions:
The majority of particles were found to be between 5 and 11 µm with 22.43 % between 2.5 and 5 µm
Executive summary:

5 -11 µm accounted for the majority of the distribution of the particles with around one quarter between 2.5 and 5 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D70
Mean:
5 - 11 µm
Remarks on result:
other: 70.17 % were found to be between 5 and 11 µm.
Percentile:
other: D25
Mean:
2.5 - 5 µm
Remarks on result:
other: 27.33 % of the particles were found between 2.5 and 5 µm
Conclusions:
The majority of particles were found to be between 5 and 11 µm, with around one quarter distributed between 2.5 and 5 µm.
Executive summary:

5 -11 µm accounted for the majority of the distribution of the particles with one quarter accounted for between 2.5 and 5 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D75
Mean:
5 - 11 µm
Remarks on result:
other: 76.14 % were found to be between 5 and 11 µm.
Percentile:
other: D20
Mean:
2.5 - 5 µm
Remarks on result:
other: 20.09 % of the particles were found between 2.5 and 5 µm
Conclusions:
The majority of particles were found to be between 5 and 11 µm, with around one quarter distributed between 2.5 and 5 µm.
Executive summary:

5 -11 µm accounted for the majority of the distribution of the particles with one fifth accounted for between 2.5 and 5 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D80
Mean:
5 - 11 µm
Remarks on result:
other: 78.48 % were found to be between 5 and 11 µm.
Percentile:
other: D20
Mean:
2.5 - 5 µm
Remarks on result:
other: 19.23 % of the particles were found between 2.5 and 5 µm
Conclusions:
The majority of particles were found to be between 5 and 11 µm, with around one quarter distributed between 2.5 and 5 µm.
Executive summary:

5 -11 µm accounted for the majority of the distribution of the particles with one fifth accounted for between 2.5 and 5 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D45
Mean:
10 - 15 µm
Remarks on result:
other: 43.80 % were found to be between 5 and 11 µm.
Percentile:
other: D20
Mean:
15 - 20 µm
Remarks on result:
other: 19.98 % of the particles were found between 15 and 20 µm.
Percentile:
other: D25
Mean:
5 - 10 µm
Remarks on result:
other: 25.24 % were distributed between 5 and 10 µm
Conclusions:
Nearly half the particles were distributed between 10 and 15 µm with roughly 20 % between 15 and 20 µm and 25 % between 5 and 10 µm.
Executive summary:

Nearly half the particles were distributed between 10 and 15 µm with roughly 20 % between 15 and 20 µm and 25 % between 5 and 10 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: 30
Mean:
10 - 15 µm
Remarks on result:
other: 31.73 % were found to be between 5 and 10 µm.
Percentile:
other: D30
Mean:
15 - 20 µm
Remarks on result:
other: 32.68 % of the particles were found between 15 and 20 µm.
Percentile:
other: D20
Mean:
5 - 10 µm
Remarks on result:
other: 21.46 % were distributed between 5 and 10 µm
Percentile:
other: D15
Mean:
20 - 25 µm
Remarks on result:
other: 13.13 % were distributed between 20 and 25 µm.
Conclusions:
10-15 and 15-20 µm each represented one third of the distribution of the particles. Around 15 % were distributed around 20-25 µm and 20 % around 5-10 µm.
Executive summary:

10-15 and 15-20 µm each represented one third of the distribution of the particles. Around 15 % were distributed around 20-25 µm and 20 % around 5-10 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
other: D35
Mean:
10 - 15 µm
Remarks on result:
other: 35.41 % were found to be between 5 and 11 µm.
Percentile:
other: D25
Mean:
5 - 10 µm
Remarks on result:
other: 24.91 % of the particles were found between 5 and 10 µm.
Percentile:
other: D30
Mean:
15 - 20 µm
Remarks on result:
other: 27.21 % were distributed between 15 and 20 µm
Conclusions:
10-15 and 15-20 µm each represented one third of the distribution of the particles. Around one quarter were distributed around 5-10 µm.
Executive summary:

10-15 and 15-20 µm each represented one third of the distribution of the particles. Around one quarter were distributed around 5-10 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Particle size was determined by transmission light microscopy using the picture-analysis software Aquinto. The surface are in the protocoll is calculated to apply to smooth spheres. Scanning electron microscopy images of the sample was included.
GLP compliance:
not specified
Type of distribution:
volumetric distribution
Percentile:
D50
Mean:
22 µm
St. dev.:
3.55
Remarks on result:
other: maximum diameter 31.05 µm
Percentile:
D95
Mean:
15 - 28 µm
Remarks on result:
other: 94.13 % of the particles were distributed between 15 and 28 µm
Conclusions:
The majority of the particles fell between 15 and 28 µm. The particles had a mean diameter of 22 µm (standard deviation of 3.55 µm) and a maximum diameter of 31.05 µm.
Executive summary:

The majority of the particles fell between 15 and 28 µm (94.13 %), with around 5 % <15 µm. The particles had a mean diameter of 22 µm (standard deviation of 3.55 µm) and a maximum diameter of 31.05 µm.

Description of key information

Particles of varying sizes were used to fulfil the information requirements as laid down in Regulation EC 1907-2006, these were as follows:

Type 7 Sn powder D90 = 5 - 11 µm

Respirable Sn powder D50 3.211 µm (with the majority of particles of diameter 3 - 3.5 µm)

Type 5 Sn powder D95 = 15 - 28 µm

Particle size analysis data are available on each lot and charge number of Sn powder used in the studies contained within this dossier.

Additional information

Particle size distribution data have been included for the various tin particles used in the studies which were conducted to fulfil the data requirements as laid down in Regulation (EC) No. 1907/2006.

Toxicology tests were conducted with a "type 7" tin metal powder the majority of particles (D90) having a diameter of between 5 and 11 µm. This particle size was selected for toxicology testing since the "type 7" powder is the smallest particle size that is available on the EU market. It was therefore used to represent the worst case scenario since it was assumed that particles of this size would be most available to the body and therefore most likely to cause an adverse effect. However, since the majority particles are too big to be respirable, it was not considered appropriate to use the "type 7" powder for inhalation studies. A powder of respirable size was sourced from outside the EU and was specially manufactured for use in the acute inhalation study. Again, use of this powder was deemed to represent the worst case scenario. The median diameter of the respirable powder was 3.211 µm with the majority of particles of diameter 3 - 3.5 µm.

Ecotoxicology studies were conducted with a "type 5" tin metal powder the majority of particles (D95) having a diameter of between 15 and 28 µm. This particle size was selected for testing since guidance states that eco-toxicology testing should be conducted with a material with the smallest representative size on the EU market. Although the "type 5" powder is not the smallest available particle size in the EU it is definitely the most representative particle size on the EU market with its main use in tin-based solders. Indeed, over half of the amount of tin that is produced is used in tin-based solder. Furthermore, the "type 5" powder is still relatively fine and a similar level of metal release is expected from the "type 5" powder compared to the "type 7" powder.